17 Sep What is a Biotechnology Cleanroom? Understanding the Basics

In biotechnology, without the right environment, processes like vaccine production or scientific research can be easily compromised. Lack of contamination is often the difference between success and failure, and as a result, cleanrooms have become the backbone of many biotechnology operations. In this article, we’ll cover what biotechnology cleanrooms are, their relevant ISO classifications, applications, and more.

What is a Biotechnology Cleanroom?

A biotechnology cleanroom is a highly controlled environment where airborne particles are limited in both size and number. The purpose of such a space is to keep the environment as clean as biotech processes require (and this of course, can vary greatly). Such cleanrooms are used in the production of biopharmaceuticals, vaccines, gene therapy, and more.

ISO Cleanroom Classifications in Biotechnology

In general, cleanrooms are made to fit certain classifications (ISO), which are determined by the number and size of particles allowed in the air. Each biotechnology application may require different classifications, but the most common cleanroom classification is perhaps ISO Class 5.

As we alluded to before, the ISO classification for each space will differ depending on what needs to be done within the space, and as biotechnology covers a wide variety of different fields, needs will also change with the specific processes being performed, such as research, development, or large-scale production.

In many cases, biotechnology cleanrooms will need to be stricter than ISO 5, such as ISO Class 4 or ISO Class 3. (The lower the number of the ISO class, the stricter the environment must be; or, in other words, the fewer particles they allow.)

What are the Applications of Biotechnology Cleanrooms?

Biotechnology cleanrooms are important for many applications, from research to large-scale manufacturing. Here are some of the most common applications.

Biopharmaceutical Manufacturing

Cleanrooms are important in producing biopharmaceuticals and protect the various biological processes that need to occur in sterile environments. If these processes are contaminated, batches of products can be ruined or pose risks to patients.

Vaccine Production

During vaccine production, the risk of contamination is also high. Cleanrooms significantly lower the chances of particles affecting the purity of vaccines.

Research and Development (R&D)

In research labs, especially those working with live cells or genetically modified organisms (GMOs), cleanrooms prevent disruption to experiments. Small particles and microorganisms can act as added variables that can sway the results of scientific experiments and render them unreliable.

Cell and Gene Therapy

Cell and gene therapy involves working with live cells, and these are very sensitive to contamination. As a result, cleanrooms help keep cells viable during therapies by preventing foreign particles from affecting treatments.

How Do Biotechnology Cleanrooms Prevent Contamination?

Biotechnology cleanrooms have many different features to help prevent contamination, almost too many to name. Below, we will highlight some of the most significant elements that keep them clean.

Advanced Filtration Systems

This is perhaps the most important element of any biotechnology cleanroom. Such spaces almost always have HEPA (high-efficiency particulate air) or ULPA (ultra-low penetration air) filters, which are dense and can capture very small particles; in fact, they can trap over 99% of them.

Personnel Protocols

The biggest contamination risk in biotechnology cleanrooms is often from the workers themselves. As a result, staff and personnel must follow strict protocols regarding cleaning, gowning, and operating procedures. Depending on how strict the cleanroom is, this may include gowns, gloves, masks, boots, and more. Special tools like air showers are also used before entering cleanroom areas to remove particles from clothing.

Airflow Control

Since biotech cleanrooms in general are quite strict, these spaces often must use laminar or unidirectional airflow, which is essentially airflow that moves in a single direction at a certain speed. This type of airflow helps direct particles away from critical areas, equipment, and processes.

Additionally, air pressure (whether positive or negative) is used to either prevent particles from flowing in from outside spaces or vice versa.

Controlling the flow of air is important in making sure that particles move in the right direction, whatever the application may be.

The Bottom Line

As we’ve seen, biotechnology cleanrooms are important in many aspects of development and research within the industry, from vaccine production to gene therapy. By using advanced filtration technology, strict cleanroom protocols, and carefully designed airflows, these spaces create the contamination-free environment necessary to create high-tech products and treatments. As biotechnological solutions continue to grow and evolve, cleanrooms will continue to be a necessary part of operations.

Interested in adding a biotech cleanroom to your location? Reach out to Allied Cleanrooms today to get a free quote on a new buildout.

FAQs About Biotechnology Cleanrooms

1. Can biotechnology cleanrooms be customized for specific processes?

Yes, of course. Biotechnology cleanrooms can be customized to meet the specific requirements of each application. Customizations can include the level of filtration, air pressure, temperature, humidity control, and materials used for construction.

2. What materials are used to construct biotechnology cleanrooms?

Cleanrooms in general are made using non-porous, easy-to-clean materials so that particles cannot accumulate in hard-to-reach places. Common materials include stainless steel, coated aluminum, or vinyls. Floors, walls, and ceilings may use coving to prevent any gaps where particles may build up.

3. What is the role of temperature and humidity in a biotechnology cleanroom?

Temperature and humidity, as in many other cleanrooms, are tightly controlled in biotechnology applications. Temperature and humidity can affect microbial growth, so it must be managed with extra care in these spaces.